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Lenvatinib medicine composition and preparation method thereof

A technology of lenvatinib and its composition, which is applied in the field of pharmaceutical composition containing lenvatinib or its salt and its preparation, can solve the problem of reducing the dissolution rate, easy increase of moisture in the pharmaceutical composition, inability to ensure product stability and Dissolution and other problems, to achieve the effect of improving compliance, improving drug compliance, and improving the advantages of clinical use

Active Publication Date: 2021-01-08
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Moreover, the basic inorganic salts mentioned in the above patents, such as potassium carbonate and sodium carbonate, have strong hygroscopicity. After long-term storage, the water content of the pharmaceutical composition is likely to increase, which is more likely to promote the degradation of the drug, and lead to methanesulfonic acid. Hydration and gelation of lenvatinib, thereby reducing the dissolution rate
Therefore, the above-mentioned technical scheme still has the defect of not being able to ensure product stability and stripping

Method used

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  • Lenvatinib medicine composition and preparation method thereof
  • Lenvatinib medicine composition and preparation method thereof
  • Lenvatinib medicine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-7

[0059] Embodiment 1-7 prescription is as follows:

[0060]

[0061]

Embodiment 1-5

[0062] Embodiment 1-5 preparation technology:

[0063] Prepare lenvatinib mesylate, aluminum magnesium carbonate, microcrystalline cellulose (2 / 3 amount), mannitol, and low-substituted hydroxypropyl cellulose in the above prescription ratios, mix well and use high-speed stirring to prepare Granulation device, adding hydroxypropyl cellulose aqueous solution for wet granulation. The obtained wet granules were dried at 60° C., sieved and sized. Add talcum powder and microcrystalline cellulose (1 / 3 amount) to the sized granules according to the prescription ratio in the above table, and mix well. The granules obtained are respectively filled in No. 2 hard capsules (Example 2, 3) or No. 3 hard capsules (Example 1, 4, 5, 6, 7), and are packaged to prepare capsules containing the composition of the present invention agent.

Embodiment 6-7

[0064] Embodiment 6-7 preparation technology:

[0065] Prepare lenvatinib mesylate, aluminum magnesium carbonate, pregelatinized starch (2 / 3 amount), lactose, and low-substituted hydroxypropyl cellulose in the above prescription ratios, mix well and granulate with high-speed stirring device, adding hydroxypropyl cellulose aqueous solution for wet granulation. The obtained wet granules were dried at 60° C., sieved and sized. Add talcum powder and pregelatinized starch (1 / 3 amount) to the sized granules according to the prescription ratio in the above table, and mix well. The obtained granules were respectively filled into No. 3 hard capsules, and packaged to prepare capsules containing the composition of the present invention.

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PUM

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Abstract

The invention provides a new Lenvatinib medicine composition and a preparation method thereof. The medicine composition contains Lenvatinib or pharmaceutically acceptable salt of the Lenvatinib and ananti-acid anti-bile gastric mucosa protective agent, wherein the protective agent is hydrotalcite. The medicine composition can fully guarantee that a product is dissolved out, medicine degradation is avoided, and the quality of the product is more favorably guaranteed.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a pharmaceutical composition containing lenvatinib or a salt thereof and a preparation method thereof. Background technique [0002] Lenvatinib, English name is: Lenvatinib, chemical name: 4-(3-chloro-4-(cyclopropylaminocarbonyl) aminophenoxy)-7-methoxy-6-quinolinecarboxamide, its The molecular formula of mesylate is: C 21 h 19 ClN 4 o 4 CH 4 o 3 S, molecular weight: 522.96, chemical structural formula: [0003] [0004] Lenvatinib is a variety of tyrosine kinase RTKs inhibitors, can inhibit the activity of VEGFR1, VEGFR2, VEGFR3, and also inhibit FGFR, PDGFRKIT, RET, thereby inhibiting tumor angiogenesis and tumor progression. It is used as a preventive and therapeutic agent for various tumors such as thyroid cancer, lung cancer, melanoma, and pancreatic cancer, and has an inhibitory effect on the metastasis of these tumors. Developed by Eisai Pharmaceuticals,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/47A61K47/02A61K33/10A61P35/00A61P1/04A61P1/00
CPCA61K31/47A61K33/10A61K47/02A61P1/00A61P1/04A61P35/00A61K2300/00
Inventor 李章才齐海军彭兴春江一帆岳蓉白小微王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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